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Completed

NCT Number: NCT01024855

Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Hyperopia Refractive Errors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Abbott Medical Optics Inc.

Santa Ana, California, 92705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • were at least 18 years old;
  • were experienced contact lens wearers;
  • were correctable to at least 20/40 or better in both eyes with contact lenses;
  • were in good general health, with healthy eyes (other than requiring vision correction);
  • had not worn lenses for at least 12 hours before each baseline visit;
  • had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
  • had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion criteria

  • had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
  • required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
  • had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
  • were currently participating in any other clinical study;
  • had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Treatment and study plan

RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)

Device

multi-purpose lens care solution

Primary outcomes

  1. Number of Eyes With No Change in Corneal Staining

    Time frame: Change from baseline after 1, 2, 4 and 6+ hours of wear

    Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2009
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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